Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the treatment of hepatitis c in patients taking stribild.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saint Michael's Medical Center
• Treatments: Cobicistat; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Ribavirin; Sofosbuvir; Tenofovir

Criteria

Inclusion Criteria:

• 18 years of age or older

• Chronic HCV genotype 1 infection

• Receiving emtricitabine/tenofovir/cobicistat/elvitegravir for at least 8 weeks.

• CD4 count >200 cells/mm3 at screening and no CD4 count <200 in previous 12 weeks

• HIV RNA PCR <50 copies/ml at screening and no HIV RNA PCR > 200 copies/ml in previous 12 weeks

Exclusion Criteria:

• History of integrase inhibitor resistance

• History of integrase inhibitor failure

• Absolute neutrophil counts under 1500/mm3 ( Black/ African Americans <1200/mm3

• Patients with cirrhosis

• Platelet count under 90,000 per cubic millimeter

• Hemoglobin levels <11 gm/dl in women or <12 gm/dl in men

• Previous treatment with a DAA

• Hepatocellular carcinoma

• AFP>100 ng/mL

• hepatitis B virus (HBsAg positive)

• Evidence of decompensated liver disease including, but not limited to, a history of presence of clinical ascites, bleeding varices, or hepatic encephalopathy